Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter (REDUCE AF)
Typical Atrial Flutter, Risk Factors With Future Development of Atrial Flutter
About this trial
This is an interventional treatment trial for Typical Atrial Flutter focused on measuring typical aflutter (AFLT), CTI ablation, Atrial Fibrillation (AF), PVI
Eligibility Criteria
Inclusion Criteria:
All patients with typical AFLT confirmed by a 12-lead ECG that are referred for ablation and manifest ≥ 2 risk factors associated with future development of AF will be eligible to participate in the study.
Risk factors for predicting future occurrence of AF will include:
- prior remote history of AF (≤ 2 episodes ≥ 1 year from the date of evaluation for study participation),
- LA size > 4.0 cm,
- left ventricular ejection fraction (LVEF) ≤ 50%,
- hypertension, and/or 5) obstructive sleep apnea.
Exclusion Criteria:
- Subjects with documented ≥ 2 AF episodes within the preceding 6 months of enrollment,
- inability or unwillingness to take 6 weeks of oral anticoagulation after the procedure and
- failure to provide informed consent.
Sites / Locations
- Hospital of the University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
CTI ablation only
CTI ablation and PVI.
subjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Atrial flutter
subjects undergoing cavo-tricuspid isthmus (CTI) ablation for Atrial flutter and pulmonary vein isolation (PVI) for Atrial Fibrillation.